Outcomes of Incentive Spirometry for Patients Undergoing Coronary Artery Bypass Surgery: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Partial Pressure of Oxygen (PaO2)
研究概览
简要总结
Background: Incentive spirometry is used in addition to care, especially in reducing pulmonary complications after surgery. Complications in the cardiovascular and pulmonary systems can basically be determined by blood values and vital signs, which are important objective data of haemodynamics.
Aim: This study was designed to test the hypothesis that the use of incentive spirometry in conjunction with postoperative pulmonary rehabilitation care has a notable impact on arterial blood gas, oxygen saturation (SpO2), and vital signs.
Methods: This randomised, controlled trial was designed using a repeated-measures design. The study was planned to be conducted at the cardiovascular surgery clinic of a university hospital. It was intended that data from patients undergoing coronary artery bypass graft surgery would be analyzed. All patients were planned to receive routine pulmonary rehabilitation, with incentive spirometry added for the experimental group. Outcome measures were designed to include arterial blood gas values, oxygen saturation, and vital signs recorded during the postoperative period.
详细描述
This study was designed as a single-center, randomized controlled trial with repeated measures to evaluate the effects of incentive spirometry used in addition to routine postoperative pulmonary rehabilitation in patients undergoing coronary artery bypass graft surgery.
The study was planned to be conducted in the cardiovascular surgery clinic of a university hospital. Patients assessed for eligibility were to be randomized into two groups: an experimental group (receiving incentive spirometry plus routine pulmonary rehabilitation) or a control group (receiving routine pulmonary rehabilitation only).
Randomization was performed using a simple randomization method with a computer-generated random number table. Group assignments were placed in sequentially numbered sealed envelopes to ensure allocation concealment. A single-blind approach was used during randomization, where the principal investigator and the statistician remained blinded to group assignments.
In the experimental group, it was planned that patients would receive routine pulmonary rehabilitation together with incentive spirometry. The device intended for use was a flow-oriented incentive spirometer with three chambers (target volumes: 600, 900, and 1200 mL). The intervention was planned to be initiated postoperatively after extubation and continued throughout the hospital stay. The procedure involved 10 to 20 deep breaths every 1 to 2 hours, combined with coughing exercises.
The control group was planned to receive routine pulmonary rehabilitation care without incentive spirometry. This care included deep breathing and coughing exercises, pain assessment, and early mobilization. Early mobilization was planned for both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing first-time, nonemergency coronary artery bypass graft surgery
- •Patients who agreed to participate in the study
- •Patients who were able to communicate
- •Patients with no hearing difficulty
- •Patients with no history of psychiatric and/or mental illness
- •Patients with a stable clinical condition
排除标准
- •Patients with an unstable clinical condition
- •Patients who refused to participate
- •Patients with chronic obstructive pulmonary disease
- •Patients with chronic kidney failure
- •Patients with severe hemodynamic dysfunction
- •Patients requiring sternotomy or re-sternotomy
- •Patients requiring prolonged mechanical ventilation
研究组 & 干预措施
Control group
Participants in the control group received routine postoperative pulmonary rehabilitation care without incentive spirometry. Routine care included deep breathing exercises, coughing exercises, pain assessment and management, and early mobilization during hospitalization. Arterial blood gas parameters, peripheral oxygen saturation, and vital signs were measured and recorded during the resting period at the end of postoperative days 1, 2, and 3.
Incentive Spirometry Group
Participants in the experimental group received routine postoperative pulmonary rehabilitation care plus incentive spirometry. Routine care included deep breathing exercises, coughing exercises, pain assessment and management, and early mobilization during hospitalization. Incentive spirometry was explained, demonstrated, and applied preoperatively and continued after extubation when the patient was fully awake. The intervention included 10 to 20 breaths every 1 to 2 hours according to patient tolerance. Arterial blood gas parameters, peripheral oxygen saturation, and vital signs were measured and recorded during the resting period at the end of postoperative days 1, 2, and 3.
干预措施: Incentive Spirometry Group (Device)
结局指标
主要结局
Partial Pressure of Oxygen (PaO2)
时间窗: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3
Measurement of the partial pressure of oxygen (mmHg) obtained via arterial blood gas analysis to evaluate oxygenation levels.
Partial Pressure of Carbon Dioxide (PaCO2)
时间窗: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
Measurement of the partial pressure of carbon dioxide (mmHg) obtained via arterial blood gas analysis to evaluate ventilation efficiency.
Arterial Oxygen Saturation (SaO2)
时间窗: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
Measurement of the arterial oxygen saturation percentage (%) obtained via arterial blood gas analysis.
Peripheral Oxygen Saturation (SpO2)
时间窗: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
Measurement of the peripheral oxygen saturation percentage (%) using a non-invasive pulse oximetry device.
次要结局
- Change in Systolic Blood Pressure(Preoperative, postoperative day 1, postoperative day 2, postoperative day 3)
- Change in Diastolic Blood Pressure(Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.)
- Change in Respiratory Rate(Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.)
- Change in Pulse Rate(Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.)
研究者
Esma Gökçe
Principal Investigator (MSc)
Cukurova University